Download - ISO 9001:2015 Status of the Revision Work
ISO 9001:2015
Status of the Revision Work
Anni Koubek ISO 9001 Revision 1
Innovations and Developments - Overview
Anni Koubek ISO 9001 Revision 2
ISO 9001
ISO 14001 OHSAS 18001
ISO 17021 ISO 19011
ISO 31000 et seqq. ISO 26000ONR 192 500
ISO 50001
ISO Directives Annex SL
EN 15224
ISO 17024ISO 17065ISO 17020
ISO 29990EFQM Excellence Model
ISO 22301
Big revision in process Start in Bilbao in June 2012 First committee draft created Titel and purpose stay unchanged Simultaneous revision of ISO 9000
Anni Koubek ISO 9001 Revision 3
ISO 9001
1987 First edition Contractual standard
1994 Small revision State of the art
2000 Big revision Processes & Improvements
2008 Small revision Supply chain included
Looking back: The Development of ISO 9001
Anni Koubek ISO 9001 Revision 4
ISO 9001
Preliminary studies on possible concepts have been completed at the end of 2010
A public survey of users has been carried out Systematic Review of ISO-full members;
15th of March, 2012: the majority has voted for revision of ISO 9001
The harmonized concept is mandatory (cf. “Annex SL” ISO Directives – about 40 % of the text will be affected)
Preliminary Work on the Current Revision
Anni Koubek ISO 9001 Revision 5
ISO 9001
Timetable of the Revision ISO 9001
ISO 9001
First consolidated draft (CD) published in June 2013
First public draft (DIS) around the beginning of 2014
Planned date of issue: 2015
Anni Koubek ISO 9001 Revision 6
The New Structure of Chapters
4. Context of the Organization 5. Leadership 6. Planning 7. Support 8. Operation 9. Performance Evaluation 10. Improvement
Anni Koubek ISO 9001 Revision 7
ISO 9001
4.1 Understanding the Organization and its Context/Determining the Relevant Context of the Organization Only implicitly contained in 9001:2008 (0.1, 4.1, 5.3a) In future: clear requirements Context regarded as external environment, drivers and
trends, and internal framework conditions
Anni Koubek ISO 9001 Revision 8
ISO 9001
4.2 Understanding the Needs and Requirements of Interested Parties/Requirements of the Interested Parties Determining relevant interested parties and identifying their
requirements Interested parties restricted to the objectives of the standard
A chance for integrativequality management
Anni Koubek ISO 9001 Revision 9
ISO 9001
Key Elements
Process oriented approach- A general overview presented (requirements of section 4)
Risks and Opportunities- System & processes planned according to risks of the specific
organisations- The term preventive actions has been dropped
Anni Koubek ISO 9001 Revision 10
ISO 9001
7.5 Documented Information
Familiar terms like “document”, “record”, “procedure” are not used in the common text.
More self-responsibility, which information has to be present in documented form;
No required documented procedures for control of documents or control of records
Anni Koubek ISO 9001 Revision 11
ISO 9001
Further Approaches and Elements
More focus on change management Development – broader interpreted with focus on
development transfer alignment with the strategic focus of the organization as a
requirement „internal and external sourcing“ replace the terms
„purchasing“ and „outsourcing“ Knowledge management elements included
Anni Koubek ISO 9001 Revision 12
ISO 9001